Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1996-2021 | Class II | Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the... | Flowonix Medical Inc | LKK | |
| Z-2078-2021 | Class II | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen... | Owen Mumford USA, Inc. | FMI | |
| Z-1966-2021 | Class II | Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI... | Edwards Lifesciences LLC | DXO | |
| Z-1965-2021 | Class II | Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE... | Edwards Lifesciences LLC | DXO | |
| Z-1964-2021 | Class II | Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE... | Edwards Lifesciences LLC | DXO | |
| Z-1963-2021 | Class II | Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use... | Edwards Lifesciences LLC | DXO | |
| Z-1962-2021 | Class II | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI... | Edwards Lifesciences LLC | DXO | |
| Z-1961-2021 | Class II | Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring... | Edwards Lifesciences LLC | DXO | |
| Z-1960-2021 | Class II | Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring... | Edwards Lifesciences LLC | DXO | |
| Z-1959-2021 | Class II | Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set... | Edwards Lifesciences LLC | DXO | |
| Z-2080-2021 | Class II | Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium... | MEDLINE INDUSTRIES, LP - Northfield | FRL | |
| Z-2141-2021 | Class II | OxyMask O2 Adult REF OM-1125-14 | Southmedic Inc. | CCK | |
| Z-1997-2021 | Class II | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No... | Remote Diagnostic Technologies Ltd. | MHX | |
| Z-2139-2021 | Class II | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. | GE Healthcare | MHX | |
| Z-2038-2021 | Class II | Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product... | Medtronic, Inc. | PUI | |
| Z-2037-2021 | Class II | Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage... | Medtronic, Inc. | PUI | |
| Z-2036-2021 | Class II | Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number... | Medtronic, Inc. | PUI | |
| Z-2035-2021 | Class II | Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442... | Medtronic, Inc. | PUI | |
| Z-2034-2021 | Class II | Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage... | Medtronic, Inc. | PUI | |
| Z-2033-2021 | Class II | Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended... | Medtronic, Inc. | PUI | |
| Z-2032-2021 | Class II | Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product... | Medtronic, Inc. | PUI | |
| Z-2031-2021 | Class II | Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product... | Medtronic, Inc. | PUI | |
| Z-2047-2021 | Class II | Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging... | Canon Medical Systems USA, Inc. | LNH | |
| Z-2046-2021 | Class II | Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use... | Canon Medical Systems USA, Inc. | LNH | |
| Z-2045-2021 | Class II | Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage... | Canon Medical Systems USA, Inc. | LNH | |
| Z-2044-2021 | Class II | Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF... | Canon Medical Systems USA, Inc. | LNH | |
| Z-1837-2021 | Class II | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product... | Sunstar Americas, Inc. | NTO | |
| Z-2030-2021 | Class II | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie... | The Binding Site Group Ltd. | DFH | |
| Z-1326-2022 | Class II | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system | Philips Medical Systems DMC GmbH | KPR | |
| Z-1329-2022 | Class II | DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system | Philips Medical Systems DMC GmbH | KPR | |
| Z-1328-2022 | Class II | DigitalDiagnost C90 High Performance. radiography and fluoroscopy system | Philips Medical Systems DMC GmbH | KPR | |
| Z-1327-2022 | Class II | DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system | Philips Medical Systems DMC GmbH | KPR | |
| Z-1325-2022 | Class II | ProxiDiagnost N90. radiography and fluoroscopy system | Philips Medical Systems DMC GmbH | JAA | |
| Z-2071-2021 | Class II | Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr... | Arrow International LLC (subsidiary of Teleflex Incorporated) | N/A | |
| Z-2070-2021 | Class II | Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | N/A | |
| Z-2069-2021 | Class II | Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr... | Arrow International LLC (subsidiary of Teleflex Incorporated) | N/A | |
| Z-2068-2021 | Class II | Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210... | Arrow International LLC (subsidiary of Teleflex Incorporated) | N/A | |
| Z-2111-2021 | Class II | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System... | Caption Health | QIH | |
| Z-2154-2021 | Class II | SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens... | CooperVision, Inc. | LPL | |
| Z-2153-2021 | Class II | FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2152-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2151-2021 | Class II | MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with... | CooperVision, Inc. | LPL | |
| Z-2150-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2149-2021 | Class II | CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens... | CooperVision, Inc. | LPL | |
| Z-2148-2021 | Class II | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2147-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2146-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker | CooperVision, Inc. | LPL | |
| Z-2145-2021 | Class II | FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2144-2021 | Class II | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV... | CooperVision, Inc. | LPL | |
| Z-2143-2021 | Class II | CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker | CooperVision, Inc. | LPL |